1. Technical Field
This invention describes methods of contraception and prophylaxis against sexually transmitted diseases (STDs), including acquired immunodeficiency syndrome (AIDS), and compositions and devices for use in such methods.
2. Background Information
There is an urgent need, worldwide, for improved contraceptives, especially male contraceptives. There is also an urgent need, worldwide, for improved prophylactic methods for preventing the spread of STDs. Vaccines could be highly valuable for meeting these needs and substantial efforts are being made to develop vaccines that will stimulate the body to synthesize its own antibodies against sperm and against STD pathogens. However, no contraceptive vaccine is yet available, and for some STDs, including AIDS, there is considerable doubt that a vaccine can ever be developedxe2x80x94infected individuals develop high titers of anti-HIV antibodies but this immunity to HIV does not stop the fatal course of AIDS.
In the absence of vaccines, the most effective methods now available for preventing both pregnancy and STDs are the condom, and the topical spermicidal contraceptivesxe2x80x94foams, jellies, suppositories, and sponges. Condoms are both contraceptive and prophylactic since they create a mechanical barrier that prevents sperm as well as STD pathogens in the ejaculate from contacting the sexual partner. Many topical contraceptives are also both contraceptive and prophylactic since they use detergents for their active (spermicidal) ingredient, usually the nonionic detergent nonoxynol-9. Detergents not only kill (lyse) sperm, they also kill many pathogenic bacteria, protozoa, and viruses. Unfortunately, detergents also injure epithelial cells, and many people cannot use topical contraceptives because the detergents cause too much irritation, especially to the urethra. Also, detergents are only active for a short time after being applied to a mucus epithelium: contraceptive suppositories start to become unreliable about 45 minutes after being inserted in the vagina because detergents become inactive after solubilizing oily molecules. Detergents are also absorbed into the body through mucus epithelia.
If used properly, condoms as well as topical contraceptives are highly effective in preventing pregnancy and disease. However, numerous studies have shown that the reliability of both these methods is limited almost entirely by xe2x80x9cuser failurexe2x80x9d. That is, the condom is not put on in time, or not at all, or the suppository is inserted too early, too late, or not at all. Such xe2x80x9cuser failurexe2x80x9d is usually due to the bother of using these prophylactic contraceptive methodsxe2x80x94they require actions and interruptions inconsistent with sexual behavior. Moreover, topically applied detergents strongly inhibit most forms of oral sex, and condoms are often disliked by men because they interfere with foreplay, reduce the sensations of intercourse, and are a bother to remove, and dispose, postcoitally.
Thus there is a need, both for men and for women, for prophylactic contraceptives that are more reliable because they are less of a bother to use and require procedures more consistent with sexual activity. The most convenient and popular methods of contraception now available (the xe2x80x9cpillxe2x80x9d, and intrauterine devices, IUDs,) provide little or no protection against STDs. Most users of these methods also need, and desire, protection against STDs, especially with the advent of AIDS.
Finally, many couples desire to conceive, and/or for religious or moral reasons do not wish to contracept, but they still need to protect each other from exchanging STDs. About one fourth of all infertile couples in the United States are infertile as a result of STDs, especially Chlamydia, an STD that is often asymptomatic and readily passes back and forth between two partners. There is thus a significant need for methods that are prophylactic against STDs but are not contraceptive. No such methods are now available.
It is a general object of this invention to provide contraceptive and/or prophylactic methods and compositions that overcome the problems inherent in the methods and compositions of the prior art by reducing the bother required in using the methods, by protecting more areas of skin and mucus epithelia at high risk for exchanging STD pathogens, and by enhancing the motivation for use by providing methods, compositions, and selections of active ingredients that more closely match all the needs and desires of individual users.
It is a specific object of this invention to create topical methods and compositions that treat, temporarily, the external surfaces of skin and mucus epithelia and do not entail the risks of delivering agents systemically (e.g., endocrine disorders that might be caused by steroidal or peptidal contraceptives, or immune disorders, including permanent infertility, that might be caused by contraceptive vaccines). Another related objective is to use as active ingredients highly specific molecules of the type naturally and abundantly present in all the mucus secretions of the body, namely antibodies, and to use these antibodies essentially as they are used by the body, by delivering to skin and mucus epithelia an appropriate selection of antibodies that will protect the user against pregnancy and/or disease.
It is another object of this invention to create a new contraceptive and/or prophylactic method for men consisting of a lotion to be applied to the external genitalia during sexual activity that includes a selection of antibodies against the sperm, toxins, and/or STD pathogens for which the user desires protection.
It is another object of this invention to create new, long-term contraceptive methods for women that will also be prophylactic: sustained release devices to be inserted in the uterus (IUDs), or in the vagina (IVDs), that release a selection of antibodies against sperm, toxins, and/or STD pathogens for which the user desires protection.
It is another object of this invention to create, for the first time, prophylactic methods for men and for women that are not contraceptive: lotions, vaginal suppositories, and IVDs that include a selection of antibodies against STD pathogens and/or toxins but no antibodies against sperm, the selection of antibodies being appropriate for individuals who simply desire protection against toxins and STDs.
It is another object of this invention to create new methods based on many of the existing contraceptive methods (such as IUDs, hormonal IVDs, and cervical caps) by making them prophylactic, as well as more reliable contraceptively, by incorporating in them sustained release devices that include a selection of antibodies appropriate for the user. Similarly, it is an object of this invention to improve many of the existing prophylactic contraceptives that use spermicides (such as suppositories, foams, jellies, sponge, and detergent-coated condoms) by including, in addition to the spermicide, a selection of antibodies appropriate for the user that will provide both longer lasting protection and better protection against spermicide-resistant STD pathogens and toxins.
It is a further object of this invention to provide contraceptive and/or prophylactic methods and compositions that are inexpensive enough to be used by individuals of all economic classes and yet, since these methods must be used repeatedly throughout the sexually active life of each individual, provide manufacturers strong profit incentives to reach the broadest possible markets.
The foregoing objects are achieved by the compositions, devices and methods of the present invention, detailed descriptions of which are given below.
Each embodiment of this invention includes a selection of one or more antibodies that best suits the desires of an individual user. For protection against the exchange of sperm (contraception) one or more antibodies that immobilize sperm in mucus are included. Similarly, for each toxin or STD pathogen for which protection is desired, one or more antibodies are included that will immobilize that toxin or STD pathogen in mucus. In each embodiment, enough of each antibody is included to deliver a dose sufficient to exert the desired immobilizing effect(s).
In one embodiment, suitable for men, the selection of antibodies desired by the user is incorporated in a pharmaceutically acceptable lotion to be applied, during sexual activity, to the external genitals and to any other area of skin or epithelium where protection against sperm, toxins, and/or STD pathogens is desired: The lotion can be directly applied by hand to all areas of skin in need of protection and indirectly by the penis and fingers to all internal mucus epithelial surfaces that may require protection (e.g., vagina, mouth, rectum).
In another embodiment, suitable for women, the selection of antibodies is incorporated in a sustained release device for insertion, and retention, in the vagina, an Intra-Vaginal Device, IVD, for the sustained release of the selection of antibodies desired by the user: such an IVD can readily be inserted, and removed by the user without the assistance of trained personnel.
In another embodiment suitable for women, the selection of antibodies is incorporated in a sustained release device for insertion and retention in the uterus, an Intra-Uterine Device, IUD, for the sustained release of the selection of antibodies desired by the user.
In another embodiment of the invention, the selection of antibodies desired by the user can be included in any of several existing contraceptive methods to enhance their contraceptive reliability and/or to add to them prophylactic efficacy against STDs and toxins e.g, sustained release devices for delivering the selection of antibodies can be incorporated in IUDs, IVDS, and cervical caps, including those devices that release hormones (e.g., progestins and estrogens) as active ingredients.
In another embodiment of the invention, the selection of antibodies desired by the user can be included in any of several detergent-based, or detergent-enhanced, prophylactic contraceptives similar to those now available, (e.g., vaginal suppositories, jellies, creams, tablets, and foams; diaphragm plus jelly, the xe2x80x9cspongexe2x80x9d, and detergent-coated condoms) to extend the duration of protection and to enhance protection against STD pathogens, especially detergent-resistant toxins and STD pathogens.
In yet another embodiment of this invention, existing detergent-based or detergent-enhanced topical and barrier contraceptives (e.g., vaginal suppositories, jellies, creams, tablets, and foams; diaphragm plus jelly, the xe2x80x9cspongexe2x80x9d, and condoms) can be converted to detergent-free methods for individuals who are highly irritated by detergents by substituting an appropriate selection of contraceptive and/or prophylactic antibodies for the detergent.